Trial Outcomes & Findings for Efficacy and Safety of QVA149 in Patients With Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT00570778)
NCT ID: NCT00570778
Last Updated: 2018-07-26
Results Overview
Spirometry testing was performed in accordance with American Thoracic Society standards. Trough FEV1 was defined as the average of the 23 hour 15 minute and 23 hour 45 minute measurements post dosing. Baseline FEV1 is the mean of the 45 minute and 15 minute pre-dose FEV1 values at day 1 of each period. Least square means are based on the Analysis of Covariance Trough FEV1 at day 7 = sequence effect + patient(sequence) + period effect + treatment effect + (period) baseline FEV1 + error.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
154 participants
Primary outcome timeframe
Baseline, Day 7
Results posted on
2018-07-26
Participant Flow
This was 4 arm crossover study. There was a 7 day washout period between each treatment period. 154 patients were randomized, 153 participants received study drug. 5 patients were excluded from the Modified Intent-to-treat population (MITT). 4 patients for protocol violations and 1 patient was randomized but did not receive study drug.
Participant milestones
| Measure |
A: Ind 300 μg- Ind 600 μg- Placebo- Ind/Glyc 300/50 μg
Treatment Period 1: One indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a single dose dry powder inhaler (SDDPI) for 7 days.
Treatment Period 2: Two indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days.
Treatment Period 3: Two placebo capsules inhaled once daily via a SDDPI for 7 days.
Treatment Period 4: One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days.
|
B: Ind 600 μg- Placebo- Ind/Glyc 300/50 μg- Ind 300 μg
Treatment Period 1: Two indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days.
Treatment Period 2: Two placebo capsules inhaled once daily via a SDDPI for 7 days.
Treatment Period 3: One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days.
Treatment Period 4: One indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a SDDPI for 7 days.
|
C: Ind/Glyc 300/50 μg- Ind 300 μg- Ind 600 μg- Placebo
Treatment Period 1: One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days.
Treatment Period 2: One indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a SDDPI for 7 days.
Treatment Period 3: Two indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days.
Treatment Period 4: Two placebo capsules inhaled once daily via a SDDPI for 7 days.
|
D: Placebo- Ind/Glyc 300/50 μg- Ind 300 μg- Ind 600 μg
Treatment Period 1: Two placebo capsules inhaled once daily via a SDDPI for 7 days.
Treatment Period 2: One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days.
Treatment Period 3: One indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a SDDPI for 7 days.
Treatment Period 4: Two indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
41
|
38
|
37
|
38
|
|
Overall Study
Safety Population: Received Study Drug
|
41
|
38
|
36
|
38
|
|
Overall Study
Modified Intent-to-treat Population
|
40
|
37
|
35
|
37
|
|
Overall Study
COMPLETED
|
37
|
34
|
30
|
34
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
7
|
4
|
Reasons for withdrawal
| Measure |
A: Ind 300 μg- Ind 600 μg- Placebo- Ind/Glyc 300/50 μg
Treatment Period 1: One indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a single dose dry powder inhaler (SDDPI) for 7 days.
Treatment Period 2: Two indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days.
Treatment Period 3: Two placebo capsules inhaled once daily via a SDDPI for 7 days.
Treatment Period 4: One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days.
|
B: Ind 600 μg- Placebo- Ind/Glyc 300/50 μg- Ind 300 μg
Treatment Period 1: Two indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days.
Treatment Period 2: Two placebo capsules inhaled once daily via a SDDPI for 7 days.
Treatment Period 3: One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days.
Treatment Period 4: One indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a SDDPI for 7 days.
|
C: Ind/Glyc 300/50 μg- Ind 300 μg- Ind 600 μg- Placebo
Treatment Period 1: One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days.
Treatment Period 2: One indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a SDDPI for 7 days.
Treatment Period 3: Two indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days.
Treatment Period 4: Two placebo capsules inhaled once daily via a SDDPI for 7 days.
|
D: Placebo- Ind/Glyc 300/50 μg- Ind 300 μg- Ind 600 μg
Treatment Period 1: Two placebo capsules inhaled once daily via a SDDPI for 7 days.
Treatment Period 2: One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days.
Treatment Period 3: One indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a SDDPI for 7 days.
Treatment Period 4: Two indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days.
|
|---|---|---|---|---|
|
Overall Study
Protocol deviation
|
2
|
1
|
2
|
2
|
|
Overall Study
Adverse Event
|
0
|
1
|
4
|
1
|
|
Overall Study
Subject withdrew consent
|
0
|
1
|
0
|
1
|
|
Overall Study
Abnormal test procedure
|
1
|
0
|
0
|
0
|
|
Overall Study
Unsatisfactory therapeutic effect
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
|
Overall Study
Subject no longer requires study drug
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Efficacy and Safety of QVA149 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Baseline characteristics by cohort
| Measure |
Overall Population
n=153 Participants
Participants were randomized and received the following 4 treatments: 1-Two placebo capsules inhaled once daily via a SDDPI for 7 days, 2-One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days, 3-One Indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a SDDPI for 7 days and 4-Two Indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days. There was a 7 day washout period between the four treatment periods.
|
|---|---|
|
Age, Continuous
|
61.7 years
STANDARD_DEVIATION 8.5 • n=99 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
94 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 7Population: Participants from the Modified Intent-to-treat population (includes all participants who received study drug) with data available for analysis.
Spirometry testing was performed in accordance with American Thoracic Society standards. Trough FEV1 was defined as the average of the 23 hour 15 minute and 23 hour 45 minute measurements post dosing. Baseline FEV1 is the mean of the 45 minute and 15 minute pre-dose FEV1 values at day 1 of each period. Least square means are based on the Analysis of Covariance Trough FEV1 at day 7 = sequence effect + patient(sequence) + period effect + treatment effect + (period) baseline FEV1 + error.
Outcome measures
| Measure |
Indacaterol/Glycopyrrolate 300/50 μg
n=140 Participants
One indacaterol/glycopyrrolate 300/50 μg capsule + 1 placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
|
Indacaterol 300 μg
n=138 Participants
One capsule indacaterol 300 μg + one placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
|
Indacaterol 600 μg
n=140 Participants
Two indacaterol 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
|
Placebo
n=136 Participants
Two placebo capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
|
|---|---|---|---|---|
|
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 7
|
1.512 Liters
Standard Error 0.0143
|
1.389 Liters
Standard Error 0.0144
|
1.395 Liters
Standard Error 0.0143
|
1.286 Liters
Standard Error 0.0145
|
SECONDARY outcome
Timeframe: Day 7Population: Participants from the Modified Intent-to-treat population (includes all participants who received study drug) with data available for analysis.
Spirometry testing was performed in accordance with American Thoracic Society standards. FEV1 was assessed at 5, 15, 30 minutes, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post dose on Day 7. Standardized (with respect to time) AUC (5 minutes-12 hours) for FEV1 on day 7 was calculated using the trapezoidal rule. Least square means are based on the Analysis of Covariance: FEV1 AUC = sequence effect + patient (sequence) + period + treatment + baseline FEV1 (period) + error.
Outcome measures
| Measure |
Indacaterol/Glycopyrrolate 300/50 μg
n=142 Participants
One indacaterol/glycopyrrolate 300/50 μg capsule + 1 placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
|
Indacaterol 300 μg
n=140 Participants
One capsule indacaterol 300 μg + one placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
|
Indacaterol 600 μg
n=142 Participants
Two indacaterol 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
|
Placebo
n=140 Participants
Two placebo capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
|
|---|---|---|---|---|
|
Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve (AUC) 5 Minutes-12 Hours at Day 7
|
1.610 Liters
Standard Error 0.0180
|
1.473 Liters
Standard Error 0.0181
|
1.457 Liters
Standard Error 0.0180
|
1.317 Liters
Standard Error 0.0185
|
SECONDARY outcome
Timeframe: 47 daysPopulation: Safety population includes all participants who received at least 1 dose of study drug.
Additional information about adverse events can be found in the Adverse Event Section.
Outcome measures
| Measure |
Indacaterol/Glycopyrrolate 300/50 μg
n=142 Participants
One indacaterol/glycopyrrolate 300/50 μg capsule + 1 placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
|
Indacaterol 300 μg
n=141 Participants
One capsule indacaterol 300 μg + one placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
|
Indacaterol 600 μg
n=141 Participants
Two indacaterol 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
|
Placebo
n=143 Participants
Two placebo capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events, Serious Adverse Events and Discontinuations Due to Adverse Events
Serious Adverse Events
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events, Serious Adverse Events and Discontinuations Due to Adverse Events
Adverse Events
|
39 Participants
|
31 Participants
|
37 Participants
|
31 Participants
|
|
Number of Participants With Adverse Events, Serious Adverse Events and Discontinuations Due to Adverse Events
Discontinuations Due to Adverse Events
|
3 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
Adverse Events
Indacaterol/Glycopyrrolate 300/50 μg
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Indacaterol 300 μg
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Indacaterol 600 μg
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Indacaterol/Glycopyrrolate 300/50 μg
n=142 participants at risk
One indacaterol/glycopyrrolate 300 μg /50 μg capsule + 1 placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
|
Indacaterol 300 μg
n=141 participants at risk
One capsule indacaterol 300 μg + one placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
|
Indacaterol 600 μg
n=141 participants at risk
Two indacaterol 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
|
Placebo
n=143 participants at risk
Two placebo capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
0.70%
1/142
The number of patients in the safety population for the QAB 600 μg treatment is (N=141) compared to the safety population (N=142). One patient was mistakenly dosed with QAB149 600 μg in 2 out of 4 periods. For AEs, this patient was counted once, not twice, therefore the difference in one patient.
|
0.00%
0/141
The number of patients in the safety population for the QAB 600 μg treatment is (N=141) compared to the safety population (N=142). One patient was mistakenly dosed with QAB149 600 μg in 2 out of 4 periods. For AEs, this patient was counted once, not twice, therefore the difference in one patient.
|
0.00%
0/141
The number of patients in the safety population for the QAB 600 μg treatment is (N=141) compared to the safety population (N=142). One patient was mistakenly dosed with QAB149 600 μg in 2 out of 4 periods. For AEs, this patient was counted once, not twice, therefore the difference in one patient.
|
0.00%
0/143
The number of patients in the safety population for the QAB 600 μg treatment is (N=141) compared to the safety population (N=142). One patient was mistakenly dosed with QAB149 600 μg in 2 out of 4 periods. For AEs, this patient was counted once, not twice, therefore the difference in one patient.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.70%
1/142
The number of patients in the safety population for the QAB 600 μg treatment is (N=141) compared to the safety population (N=142). One patient was mistakenly dosed with QAB149 600 μg in 2 out of 4 periods. For AEs, this patient was counted once, not twice, therefore the difference in one patient.
|
0.00%
0/141
The number of patients in the safety population for the QAB 600 μg treatment is (N=141) compared to the safety population (N=142). One patient was mistakenly dosed with QAB149 600 μg in 2 out of 4 periods. For AEs, this patient was counted once, not twice, therefore the difference in one patient.
|
0.00%
0/141
The number of patients in the safety population for the QAB 600 μg treatment is (N=141) compared to the safety population (N=142). One patient was mistakenly dosed with QAB149 600 μg in 2 out of 4 periods. For AEs, this patient was counted once, not twice, therefore the difference in one patient.
|
0.00%
0/143
The number of patients in the safety population for the QAB 600 μg treatment is (N=141) compared to the safety population (N=142). One patient was mistakenly dosed with QAB149 600 μg in 2 out of 4 periods. For AEs, this patient was counted once, not twice, therefore the difference in one patient.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.70%
1/142
The number of patients in the safety population for the QAB 600 μg treatment is (N=141) compared to the safety population (N=142). One patient was mistakenly dosed with QAB149 600 μg in 2 out of 4 periods. For AEs, this patient was counted once, not twice, therefore the difference in one patient.
|
0.00%
0/141
The number of patients in the safety population for the QAB 600 μg treatment is (N=141) compared to the safety population (N=142). One patient was mistakenly dosed with QAB149 600 μg in 2 out of 4 periods. For AEs, this patient was counted once, not twice, therefore the difference in one patient.
|
0.00%
0/141
The number of patients in the safety population for the QAB 600 μg treatment is (N=141) compared to the safety population (N=142). One patient was mistakenly dosed with QAB149 600 μg in 2 out of 4 periods. For AEs, this patient was counted once, not twice, therefore the difference in one patient.
|
0.00%
0/143
The number of patients in the safety population for the QAB 600 μg treatment is (N=141) compared to the safety population (N=142). One patient was mistakenly dosed with QAB149 600 μg in 2 out of 4 periods. For AEs, this patient was counted once, not twice, therefore the difference in one patient.
|
Other adverse events
| Measure |
Indacaterol/Glycopyrrolate 300/50 μg
n=142 participants at risk
One indacaterol/glycopyrrolate 300 μg /50 μg capsule + 1 placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
|
Indacaterol 300 μg
n=141 participants at risk
One capsule indacaterol 300 μg + one placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
|
Indacaterol 600 μg
n=141 participants at risk
Two indacaterol 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
|
Placebo
n=143 participants at risk
Two placebo capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/142
The number of patients in the safety population for the QAB 600 μg treatment is (N=141) compared to the safety population (N=142). One patient was mistakenly dosed with QAB149 600 μg in 2 out of 4 periods. For AEs, this patient was counted once, not twice, therefore the difference in one patient.
|
2.1%
3/141
The number of patients in the safety population for the QAB 600 μg treatment is (N=141) compared to the safety population (N=142). One patient was mistakenly dosed with QAB149 600 μg in 2 out of 4 periods. For AEs, this patient was counted once, not twice, therefore the difference in one patient.
|
1.4%
2/141
The number of patients in the safety population for the QAB 600 μg treatment is (N=141) compared to the safety population (N=142). One patient was mistakenly dosed with QAB149 600 μg in 2 out of 4 periods. For AEs, this patient was counted once, not twice, therefore the difference in one patient.
|
1.4%
2/143
The number of patients in the safety population for the QAB 600 μg treatment is (N=141) compared to the safety population (N=142). One patient was mistakenly dosed with QAB149 600 μg in 2 out of 4 periods. For AEs, this patient was counted once, not twice, therefore the difference in one patient.
|
|
Infections and infestations
Nasopharyngitis
|
0.70%
1/142
The number of patients in the safety population for the QAB 600 μg treatment is (N=141) compared to the safety population (N=142). One patient was mistakenly dosed with QAB149 600 μg in 2 out of 4 periods. For AEs, this patient was counted once, not twice, therefore the difference in one patient.
|
4.3%
6/141
The number of patients in the safety population for the QAB 600 μg treatment is (N=141) compared to the safety population (N=142). One patient was mistakenly dosed with QAB149 600 μg in 2 out of 4 periods. For AEs, this patient was counted once, not twice, therefore the difference in one patient.
|
1.4%
2/141
The number of patients in the safety population for the QAB 600 μg treatment is (N=141) compared to the safety population (N=142). One patient was mistakenly dosed with QAB149 600 μg in 2 out of 4 periods. For AEs, this patient was counted once, not twice, therefore the difference in one patient.
|
3.5%
5/143
The number of patients in the safety population for the QAB 600 μg treatment is (N=141) compared to the safety population (N=142). One patient was mistakenly dosed with QAB149 600 μg in 2 out of 4 periods. For AEs, this patient was counted once, not twice, therefore the difference in one patient.
|
|
Nervous system disorders
Headache
|
4.9%
7/142
The number of patients in the safety population for the QAB 600 μg treatment is (N=141) compared to the safety population (N=142). One patient was mistakenly dosed with QAB149 600 μg in 2 out of 4 periods. For AEs, this patient was counted once, not twice, therefore the difference in one patient.
|
1.4%
2/141
The number of patients in the safety population for the QAB 600 μg treatment is (N=141) compared to the safety population (N=142). One patient was mistakenly dosed with QAB149 600 μg in 2 out of 4 periods. For AEs, this patient was counted once, not twice, therefore the difference in one patient.
|
4.3%
6/141
The number of patients in the safety population for the QAB 600 μg treatment is (N=141) compared to the safety population (N=142). One patient was mistakenly dosed with QAB149 600 μg in 2 out of 4 periods. For AEs, this patient was counted once, not twice, therefore the difference in one patient.
|
1.4%
2/143
The number of patients in the safety population for the QAB 600 μg treatment is (N=141) compared to the safety population (N=142). One patient was mistakenly dosed with QAB149 600 μg in 2 out of 4 periods. For AEs, this patient was counted once, not twice, therefore the difference in one patient.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.8%
4/142
The number of patients in the safety population for the QAB 600 μg treatment is (N=141) compared to the safety population (N=142). One patient was mistakenly dosed with QAB149 600 μg in 2 out of 4 periods. For AEs, this patient was counted once, not twice, therefore the difference in one patient.
|
0.71%
1/141
The number of patients in the safety population for the QAB 600 μg treatment is (N=141) compared to the safety population (N=142). One patient was mistakenly dosed with QAB149 600 μg in 2 out of 4 periods. For AEs, this patient was counted once, not twice, therefore the difference in one patient.
|
2.1%
3/141
The number of patients in the safety population for the QAB 600 μg treatment is (N=141) compared to the safety population (N=142). One patient was mistakenly dosed with QAB149 600 μg in 2 out of 4 periods. For AEs, this patient was counted once, not twice, therefore the difference in one patient.
|
1.4%
2/143
The number of patients in the safety population for the QAB 600 μg treatment is (N=141) compared to the safety population (N=142). One patient was mistakenly dosed with QAB149 600 μg in 2 out of 4 periods. For AEs, this patient was counted once, not twice, therefore the difference in one patient.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.4%
2/142
The number of patients in the safety population for the QAB 600 μg treatment is (N=141) compared to the safety population (N=142). One patient was mistakenly dosed with QAB149 600 μg in 2 out of 4 periods. For AEs, this patient was counted once, not twice, therefore the difference in one patient.
|
1.4%
2/141
The number of patients in the safety population for the QAB 600 μg treatment is (N=141) compared to the safety population (N=142). One patient was mistakenly dosed with QAB149 600 μg in 2 out of 4 periods. For AEs, this patient was counted once, not twice, therefore the difference in one patient.
|
2.8%
4/141
The number of patients in the safety population for the QAB 600 μg treatment is (N=141) compared to the safety population (N=142). One patient was mistakenly dosed with QAB149 600 μg in 2 out of 4 periods. For AEs, this patient was counted once, not twice, therefore the difference in one patient.
|
2.8%
4/143
The number of patients in the safety population for the QAB 600 μg treatment is (N=141) compared to the safety population (N=142). One patient was mistakenly dosed with QAB149 600 μg in 2 out of 4 periods. For AEs, this patient was counted once, not twice, therefore the difference in one patient.
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER